Optical Coherence Tomography (OCT) imaging uses near-infrared light to produce high-resolution images of various objects such as, but not limited to tissue, for example. When OCT imaging is used on tissue, it is analogous to high-frequency ultrasound, except that the optical interferometry of OCT imaging is used for depth ranging rather than echo timing. OCT imaging is rapid, non-contact, non-invasive, and capable of generating 2D and 3D images at high resolution (˜10 μm).
Current methods to measure margin width during lumpectomy procedures have been reported to result in reoperation rates of up to 20 to 60%, representing a significant and unmet need for improved margin assessment. High reoperation rates present both increased treatment risk to patients and an increased burden on healthcare systems. In the USA alone, over 150,000 lumpectomies are performed per year at an average cost of between $11,000 and $19,000 USD per procedure. Assuming an average repeat operation rate of 25%, potentially preventable repeat surgeries represent an approximate cost to the US healthcare system of $500 M (USD) annually.